1. Field of the Invention
The present invention relates to a device which is used to secure respiratory appliance to a patient during respiratory therapy. The present invention is particularly suitable for attaching nasal prongs to a newborn infant when administering continuous positive airway pressure (CPAP).
Continuous positive airway pressure refers to ventilation assisted by a flow of air delivered at a constant pressure throughout the respiratory cycle. It is performed for patients who can initiate their own respirations but who are not able to maintain adequate arterial oxygen levels without assistance. CPAP may be given through a ventilator and endotracheal tube, through nasal prongs, or through a nasopharyngeal tube.
Newborn infants who are delivered prior to term are subject to various disorders which can complicate their neonatal course. Many premature infants develop respiratory distress syndrome (RDS) or hyaline membrane disease (HMD) requiring oxygen therapy. It has been found that continuous positive airway pressure has a significant therapeutic effect on infants with hyaline membrane disease. Indeed, the major use of CPAP has been to improve arterial P.sub.02, in order to reduce F.sub.102 , in infants with HMD who do not require assisted ventilation. Avery, Neonatology (2d Ed.) 1981. However, continuous positive airway pressure is useful in treating many other respiratory problems in both infants and adults.
The basic components of a system for applying CPAP include (1) a source of gas; (2) a device for varying the pressure in the system; (3) a manometer; and (4) a means for connecting the system to the patient's airway. Since most premature infants are quite small, the most common means for applying CPAP is through nasal prongs. Due to the sensitivity of newborn infants to trauma of even the slightest degree, it is important that the respiratory appliance remain securely in place and functioning at all times. However, many of the devices available today are difficult to secure to an infant's airway due to the infant's small size, the need to move the infant regularly, and the infant's own natural movements.
2. Description of the Prior Art
Prior to the present invention, many methods were tried in an effort to secure nasal prongs to an infant's airway. One of the most common means of attaching nasal prongs to the infant is by securing the prongs with conventional surgical masks having the planar portion of the mask applied to the back of the head and secured to the extensions on either side of the prongs with the strings which extend from the mask. Also, string or gauze is often tied around the circumference of the infant's head. However, a premature infant's skull is quite soft immediately after birth and a face mask or string tends to leave ridges in the infant's skull or change the shape of the head entirely. Prior art methods of securing the nasal prongs also can cause pressure sores, or excoriation, and the prior art means are easily dislodged when the infant is moved or moves naturally.
Thus, it is an object of the present invention to provide a device for securing a respiratory appliance or the like on a patient during respiratory therapy in such a way as to distribute evenly over the head the tugging pressure caused by movement of the applicance.
It is a further object of the present invention to provide a device for securing a respiratory appliance or the like during respiratory therapy which can be adjusted to fit securely on the individual patient in need of therapy.
A still further object of the present invention is to provide a device for securing a respiratory appliance or the like during respiratory therapy which allows complete freedom of head movement without dislodging or dislocating the respiratory appliance.